2 April 2009, Brussels, European Parliament 2 Proceedings Conference NanoCap / STOA-EP Working and Living with Nanotechnologies – Trade Union and NGO positions

2 April 2009, Brussels, European Parliament

Summary The capacity building project NanoCap (2006-2009) organised a structured discussion between European Trade Unions, NGO’s and academic experts on environmental and occupational health and safety risks of nanotechnologies. This paper summarizes the results of the final conference of the NanoCap project, organised with STOA/European Parliament, to present the positions and perspectives on nanotechnologies at the workplace and in the environment adopted by these civil society organisations. It reflects the dialogue that took place in two panel discussions between trade unions, environmental NGOs, consumer organisations, employers associations, industry, European parliamentarians, the European Commission and a broad audience. The TUs and NGOs presented their respective collective European position statements. Their stance is quite positive towards the development of nanotechnologies, but characterised by an emphasis on a precautionary risk approach. Key issues are: transparency of the composition of „nanoproducts”, the need to get related risk information to be provided by the industry throughout the production chain, and responsible risk management. Initiatives like the Code of Conduct may be a helpful guide towards the responsible development of nanotechnologies. However, according to the opinion of the TUs and NGOs this type of voluntary code cannot replace binding legislation. The European Commission supports the precautionary approach and emphasizes the role of the industry in providing data and related communication on substances, as well on nanoparticles. Employers’ organisations and industry state that current legislation is sufficient to deal with nanomaterials, although it might need some modification. The European Parliamentarians, TUs and NGOs state that a good legal framework is needed to manage the possible risks associated with nanotechnology. Adaptations of existing legislation are necessary. The rapid nanotechnological developments, and the many products that are on the market, or about to reach it, legitimise the quick acceptance of precautionary measures, preferably stimulated by binding legislation. Labelling of nanoproducts and a public inventory of all products containing nanoparticles are important steps, but other steps are required such as the development of occupational exposure limits for nanoparticles. Notification of products containing nanoparticles and an obligation for employers to register workers working with these products with a possible exposure are important issues. Industry will have to play an important role in this respect. It is stated that we already know a lot about the hazardous properties of different nanoparticles, about the nanoparticles itself and from the substances of which these nanoparticles are derived. Although we know very little about the actual exposures both in the workplace and in the product chain, we know enough to derive precautionary exposure limits: to regulate in analogy. References are being made to REACH to provide the framework for nano-legislation, but adaptations are needed. Loopholes in REACH will have to be closed in the next two years. Nano - research and development should be driven by real societal needs and based on ecological, social and sustainable development considerations and not only on the ‘marketability’ of products. ‘Non-sense’ products, that is products without a real societal need and possibly polluting the environment or products with unverified claims should not be allowed on the market. The message envisaged from the actual developments of nanotechnologies is that product development is not going to wait for scientific evidence of safety or harm (which may never become available). A good legal, preferably binding legal framework is needed to manage the possible risks associated with nanotechnology.

3 Contents

1. Introduction ...... 5

2. Opening address ...... 5 Malcolm Harbour- Member European Parliament

3. Introduction to the NanoCap project ...... 5 Pieter van Broekhuizen (IVAM-NanoCap)

4. Governance and Ethics of Nanotechnologies under the Science in Society programme of the EU’s Framework Programme for Research ...... 7 Peteris Zilgalvis (Head of Unit. Ethics and Science. European Commission)

5. Nanotechnologies – Assessment of Technological Potential and Policy Implications: a STOA Perspective ...... 8 Mikos Györffi , STOA – European Parliament

6. Trade Union position, perspectives and discussion ...... 8 Joel Decallion – Secretary of the European Trade Union Confederation (ETUC)

7. Nano at work debate: next steps, implementing safe work practices and a precautionary principle ...... 9 Panel: Tony Musu (ETUI), Frank Barry (AMICIUS/UNITE Irish-British trade union), Willem-Henk Streekstra (Business Europe,) Jan Cremers (MEP), Antonis Angelidis (European Commission-DG Employment) Chairman: Ben Nemery (Medical Faculty - Catholic University Leuven)

8. Environmental NGOs position, perspectives and discussion ...... 13 John Hontelez (Secretary General of the European Environmental Bureau)

9. Nano and the environment debate - Panel discussion ...... 15 Panel: Dragomira Raeva (EEB), Laura Degallaix (BEUC), Lena Perenius (CEFIC), Carl Schlyter (MEP), Henrik Laursen (European Commission DG Environment), Lucas Reijnders (University of Amsterdam) Chairman: René von Schomberg (European Commission DG Research)

10. Conference Conclusions ...... 18 Alfred Nordmann (TU Darmstadt)

11. Closing remarks ...... 19 Mrs Dorette Corbey, MEP

ANNEX I: PowerPoint presentations

ANNEX II: Description Speakers and Panel Members

4 Proceedings European Conference „Working and Living with Nanomaterials” NanoCap/STOA, 2 April 2009

Chair of the day: Pieter van Broekhuizen (IVAM UvA B.V. – Coordinator NanoCap)

1. Introduction The results of the three-year NanoCap project were presented and discussed with a broad international audience at a conference in Brussels on 2nd April 2009. The conference was organised in cooperation with STOA (Science and Technology Options Assessment) an official organ of the European Parliament. This allowed presentations of the position statements of the European Trade Unions and environmental NGO’s within the European political context. The respective positions were publicly discussed in two subsequent panel discussions. The respective positions were publicly discussed in two subsequent panel discussions. The first discussion was presented by the Trade Unions and was orientated towards the workplace, the second discussion presented by the environmental NGOs who considered nano and the environment. The opinions of the European Parliament on the future development, and the need for legislation for nanotechnologies were presented and related to European Commission activities. There were approximately 200 participants representing the majority of the Member States of the European Union, as well as participants from Northern and Mid Africa, Asia and Canada. The professional background of the participants is presented in the following table:

Professional background of participants % Industry 26 Trade Union 17 Non Governmental Organisation 19 Consumers organisation 4 European Commission 4 European Parliament 3 Member States’ Government 7 Research Institute 19 Other 1

2. Opening address Malcolm Harbour- Member European Parliament

Harbour emphasized the difficulties of evidence based policy making in relation to nanotechnologies. He argued that a multidisciplinary approach was required to address, in depth, many nano-issues. He believed that the communication, such as that organised by NanoCap, was important to keep up the dialogue with the Parliament and with the different stakeholders.

3. Introduction to the NanoCap project Pieter van Broekhuizen (IVAM-NanoCap)

An overview to the NanoCap project was given by its coordinator, van Broekhuizen. He explained how the project was set up and provided a short overview of the results and societal demands of the NGOs and trade unions involved. NanoCap, he explained was a capacity building project for trade unions and environmental NGOs granted by the FP6 - Science & Society programme. It was conducted over the period September 2006 – September 2009 and involved 5 environmental NGOs, 5 Trade Unions and 5 Universities under the coordination of IVAM UvA (NL). The participating institutions were based in many European and (by membership of one of the partners) several non-European (North African) countries. NanoCap operated through focussed working conferences, position discussions and workplace visits. It covered the following topics: technical issues, environmental issues, occupational health and safety issues, ethical issues and benefits of nanotechnology.

5 The project has contributed to the public nanodialogue via discussions with members, authorities, industry and the public.

TUs and NGOs in the nano-discussion The conclusions to be drawn from the project was that the capacity building of NanoCap was successful in supporting Trade Unions and NGOs in developing their position statements. The increase in knowledge gained by the partners did not result in an aversion to nanotechnologies. Trade Unions and NGOs were able to develop collective European position statements, sometimes complemented with national refinements. A key role in both statements was the precautionary approach to the use of nanomaterials.

Workers’ interests in nanotechnologies The goals for Trade Unions is their aim to ensure a safe workplace for all working with nanotechnologies and nanomaterials. Nanotechnologies and manufactured nanomaterials might have considerable potential for the development and application of new products, certainly technological improvements will emerge and new jobs will be created in this field. However, the trade unions’ call for a transparent and independent risk assessment is essential. The precautionary approach should be applied in cases where data is lacking. According to their position, legislation for nanotechnologies should be realised and complied with.

NGOs interests in nanotechnologies The responsible governance of nanotechnologies and nanomaterials, along with their various applications, is crucial for environmental NGOs. The backbone of such governance is the adoption of a strict regulatory framework which will ensure environmental and human health saftey, while following the principle of sustainability. Furthermore, environmental NGOs demand that the precautionary principle should be employed in nanomaterials development and use until there is an adequate EU regulatory framework for nanomaterials oversight. At present, according to the NGOs the highest priority should be given to consumer products already on the market or in near-market stage, which should with no delay be comprehensively assessed on their human health and environmental impacts. A key challenge is to ensure that the setting up of a long term action plan, engaging all stakeholders in an open discussion, at an early stage of development of this powerful, innovative, high-end technology so as to ensure that it moves towards the resolution of many of the world’s current problems without posing environmental, social, economic and health hazards to humans and the environment.

Lessons from NanoCap It is difficult to identify products manufactured with the use of nanotechnology. At the same time, due to a lack of knowledge, it is difficult to judge the benefits from nanotechnology. Policy instruments must be used to balance the two ends of the scale: economic value (claimed benefits, replacement of scarce raw materials, stakeholder interests, “nanotech index”, new job creation) balanced against ‘acceptable’ risks (hazard and exposure assessment, risk behaviour, uncertainties). A simple weighing of the pros and cons is not possible. Taking the precautionary approach seriously is an essential but difficult task. To accept precautionary measures (possibly comparable to preventive measures), might be problematic for many companies. Initiatives like the voluntary Code of Conducts may be helpful guides but, the view of the TUs and NGOs, this that these types of voluntary systems cannot replace binding legislation.

Building blocks for a precautionary nano approach A starting point for the trade Unions and the NGOs is to make the precautionary approach more practical for industrial practice, to accept the somewhat adapted REACH adagio: no data Æ no exposure. To achieve transparency on the composition of nanoproducts, a notification obligation for manufacturers as well as suppliers of nanoparticles / nanomaterials used in products is essential. This would enable the user of such products to make a reliable risk assessment (declaration of type and amount of NP in the product to an independent body and declaration of nano-content of product through the production chain). In this respect, the Material Safety Data Sheet can be used to create a transparent risk communication The MSDS should supply information on known nano-risks, how to manage the risks, and info on the existing knowledge gaps. Additionally there is the call to provide a Chemical Safety Report (REACH) also for substances brought at the market in lower tonnages: >1 ton/year/company).

6 Proceedings European Conference „Working and Living with Nanomaterials” NanoCap/STOA, 2 April 2009

In the workplace, exposure registration should be obligatory. This could be based either on the registration for carcinogenic substances or for reprotoxic substances. Nano-OELs (occupational exposure limits) should be derived. For those nano-substances where hazard data is lacking a worst case approach could be applied by deriving nano reference values1, using well considered safety factors as proposed by NIOSH (National Institute of Occupational Safety & Health). A hazards ranking system for nanoparticles could be established as proposed by the British Standards Institute. At the same time, workers who are potentially exposed to nanomaterials should be regularly monitored to identify any adverse affects as early as possible (development of an early warning system). The building blocks can be summarised as follows:

Building blocks for a precautionary nano approach ƒ No data Æ no exposure ƒ Notification nano product composition for manufacturers and suppliers 1. Declaration of type and amount of NP in the product to an independent body 2. Declaration of nano-content of product through the production chain ƒ Exposure registration for the workplace 1. Analogue to carcinogenics registration for nano-fibres and CMRS–nanomaterials 2. Analogue to reprotox registration for other non-soluble nanomaterials ƒ Transparent risk communication 1. Information on MSDS on known nano-risks, management and knowledge gaps 2. Demand a Chemical Safety Report (REACH) for substances >1 ton/year/company ƒ Derivation of nano-OELs, nano reference values for: 1. fullerenes, SMCNT, MWCNT, Carbon Black, nano- polystyrene and dendrimers 2. Ag, Fe, TiO2, CeO2, ZnO, (amorphous)SiO2, alumina, nanoclay ƒ Development of an early warning system ƒ Measures to avoid marketing of “non-sense”products

Measures to avoid the marketing of ‘non-sense’ products Although it is almost impossible to define clear and unambiguous criteria for what type of products should be classified as ‘non-sense product’, it is clear for all CSOs that products should not be brought on the market if they introduce new, or uncertain risks to health or the environment, while their claimed good or beneficial performance cannot be substantiated.

4. Governance and Ethics of Nanotechnologies under the Science in Society programme of the EU’s Framework Programme for Research Peteris Zilgalvis (Head of Unit. Ethics and Science. European Commission)

Zilgalvis gave a brief explanation of the diversity of nanotechnologies, the evolvement of Ethics & Governance of Nanosciences and Nanotechnologies under the Science in Society Programme: ethical acceptability of technology, early identification of benefits and risks, European and international research cooperation and governance. He argued that the lessons that were learnt from the GMO debate should be taken seriously. While in the R&D stage there was public concern and involvement of all stakeholders, ethical issues have to be emphasized by the need to balance privacy and security. It is the challenge for governmental institutions, research and the industry to involve civil society actors in the discussion on nanotech research. He believes that the NanoCap project provides an example of this, creating tools to discuss the acceptability of technology. A reliable assessment and balance of product benefits against product safety is crucial. Also, mapping governance and ethics issues at EU and international levels is essential. He emphasized the current risk issues: safety, ethics, research on risks; application of precautionary principle; implementing the Code of Conduct; at the same time he highlighted that the EC is committed to public debate. The European Commission policies include: the adoption of a European strategy for nanotechnology (May 2004) and the Action Plan (June 2005) emphasizing the need for a “safe, integrated and responsible development of nanoscience and nanotechnology; announcement of the adoption of a

1 As proposed by BSI (2007)

7 Code of Conduct at international level; Implementation of International Dialogue. Now the EC recommends Member States to adopt the Code of Conduct in national policies, to be used as an instrument to encourage dialogue at all governance levels among policy makers, researchers, industry, ethics committees, civil society organisations and society at large. The deadline to inform the EC about the Member States’ activities, as stated in the EC Code of Conduct, is February 2010 (but so far, there has only one response been received); Cooperation with the EC to monitor and review the Code of Conduct biannually is foreseen. NanoCap enabled Civil Society Organisations to elaborate on views on nanotechnologies and thus to contribute to an informed public debate; its results can feed into ongoing multi-stakeholder dialogues. It is an early example of a more deliberative approach of RTD (Research and Technology Development) policy. No debate-fatigue: today is an example!

5. Nanotechnologies – Assessment of Technological Potential and Policy Implications: a STOA Perspective Mikos Györffi , STOA – European Parliament

In the presentation the mission STOA was explained. This is to provide parliamentary bodies with independent high-quality and scientifically impartial studies. This allows the identification for the best course of action which can then be carried out with the support the European Parliament (EP) in its role as legislator. STOA’s work has long-term objectives and differs from the work of the EP Secretariat General’s research departments. STOA deals with a variety of issues of science and technology covering all areas relevant to the work of the European Parliament. Outstanding research subjects of STOA in the past legislature were those associated with nanotechnologies and nanomaterials. As such the technology assessment of the convergence of nano-, bio-, info- and cognosciences was analysed and it was established as crucial factor for the control of the process and who benefits of it. Another STOA project dealt with the possibility of substituting dangerous chemicals by nanotechnology. Results stated that currently nanotechnologies cannot replace hazardous substances, but nevertheless there is considerable potential for substitution. The need for a lifecycle approach in this respect was emphasized. STOA also participated in events discussing the potential of nanotechnologies.

6. Trade Union position, perspectives and discussion Joel Decallion – Confederal Secretary of the European Trade Union Confederation (ETUC)

The European Trade Union Institute (ETUI) as partner in the NanoCap project prepared the trade unions’ positioning which was agreed by the Members of the ETUC who came together in a Nano- working Group and prepared the European Trade Union position. This was adopted as the ETUC resolution on nanotechnologies and nanomaterials in 2008. The ETUC is convinced that nanotechnologies and manufactured nanomaterials might have a positive potential in technological improvements and in the creation of new jobs, but there are concerns about potential risks to human health and to the environment; they call for an in-depth debate.

The ETUC Resolution addresses the following issues: 1. Marketing The REACH adagio “No data Æ No market” must be applied as a general frame for nanotechnological products that are intended to be introduced to the market. However, the registration procedure in REACH must be modified in order to cover all nanomaterials, including those produced or imported in quantities below 1 ton/year. At the same time, better communication and risk assessment in the workplace is needed. 2. Workers Protection: Workers and their representatives have to be involved in the organisation and performance of workplace risk assessments. As part of the precautionary approach, the Chemical Agents Directive 98/24/EC should be amended to require employers to implement risk reduction measures when the hazards of (nano)substances used are still unknown. Workers’ information about nanomaterials that may be present in products to which they are exposed to has to be

8 Proceedings European Conference „Working and Living with Nanomaterials” NanoCap/STOA, 2 April 2009

improved. To do this, safety data sheets must state whether nanomaterials are present. Training and health surveillance for workers exposed to nanomaterials is necessary, as are measures for exposure control. 3. R&D The budget for health & environmental risk research must be increased. This means at least an allocation of 15% (currently 5%) of public research budgets for nanotechnological health and environmental risk research; this holds for both at national and European level. At the same time, an essential element for all NT research projects should be the inclusion of an health & safety assessment as a compulsory part of the reporting. 4. Terminology A standardised terminology for nanomaterials is urgently needed to prepare meaningful regulatory programmes. For that reason, the ETUC calls on the European Commission to adopt a definition of nanomaterials which is not restricted to objects below 100 nanometres in one or more dimensions. 5. Legislative framework in the EU The ETUC's examination of the current legislative framework has identified several loopholes. Some regulatory changes are needed: • Amend the Chemical Agents Directive as well as REACH for a better coverage of all potentially manufactured nanomaterials. A Chemical Safety Report has to be provided for materials on the market below 1 ton/year production volume. • Apply the precautionary approach ‘No data Æ no exposure’ in the sense that workers’ exposure should be avoided as much as possible. • Voluntary initiatives and codes of practices may be useful if some conditions are met, but nanotechnologies need proper legislation. • In order to secure that the implementation of preventive measures is effective and is complied with, penalties would be a potential instrument if obligations are not complied with. 6. Consumers` protection The ETUC wants all consumer products be labeled if they contain manufactured nanoparticles which could be released under reasonable and foreseeable conditions of use or disposal. The ETUC calls on Member states authorities to set up a national register on the production, import and use of nanomaterials and nano-based products. 7. Application of the Precautionary Principle Preventive actions must be taken where uncertainty and lack of knowledge prevails. This is an essential prerequisite for the responsible development of nanotechnologies and for helping to ensure society’s acceptance of nanomaterials. The registration process at REACH is a clear example of how precautionary is applied to register substances, as well as the implementation of risk assessment for all materials.

As a final remark: Undoubtedly, there are some benefits. However, to gain more credit for those benefits, the amount of knowledge (e.g. performance and wear, environmental fate, toxicity) about nanotechnology (nanoparticles) needs to be increased.

7. Nano at work debate: next steps, implementing safe work practices and a precautionary principle Panel: Tony Musu (ETUI), Frank Barry (AMICIUS/UNITE Irish-British trade union), Willem- Henk Streekstra (Business Europe,) Jan Cremers (MEP), Antonis Angelidis (European Commission-DG Employment). Chair: Ben Nemery (Medical Faculty - Catholic University Leuven)

The Chair opened the discussion and stated that there were two important principals for implementation: 1. that the precautionary principle is the most important principle that has to be implemented in the development of nanotechnologies and 2. that life cycle assessment (LCA) is the other important principle that would be necessary to assess the impact of nano related products.

SUMMARY OF THE DEBATE

For a better understanding of that debate, the major issues discussed are summarized below.

9 Health & Safety strategy: The majority of the panellists agreed that health & safety should become an integral part of all research projects. For instance, health & safety practices regarding nanomaterials and products should be adjusted to a precautionary approach if enough reliable data are lacking. However, some of them pointed out that gaps should be identified and a strategy should be developed to fill them. As a general approach, health & safety should always be addressed in one way or another in every research project.

Legislative issues: According to industry and the European Commission, both existing EU and national legislation handle the risks properly; to their opinion current legislation is sufficient to deal with nanotechnological risks. In contrast, it was stated from the trade unions’ side, the MEP and the general audience that it is necessary to amend some current loopholes in legislation and to derive proper legislation for nanomaterials. Gaps, either in REACH or in the Chemicals Agents directive, have to be closed amended to protect workers involved in the use of nanomaterials.

Chemical Safety Report and Safety Data Sheets: As a general opinion, the panellists consented on the lack of sufficient knowledge about nanomaterials and protective measures. The differences of working between closed and opened systems, were highlighted, the industry stated that the application of the precautionary principle was precisely working in closed systems. The discussants agreed on the necessity of improving the content of the Safety Data Sheets and to extend the obligation to provide Chemical Safety Reports to the lower tonnage nano-substances as well.

Codes of Conduct: Here the debate separated into two positions. The representative of the Industry claimed that there was no need for any additional codes of conduct. On the other hand, the trade unions’ representatives outlined the difficulties of enforcing them. They highlighted the lack of compulsory measures in the event of non compliances with such voluntary Codes in the industry.

Other issues such as labelling, standardisation, patents and hazards detection, were briefly touched. The panel agreed that there was the need for more research on the health and safety and environmental aspects of nanoparticles and called for an open dialogue between all stakeholders.

DEBATE

Cremers stated that, in dealing with health & safety practices regarding nanomaterials and products, the precautionary principle should lead. At present many workers are working under conditions of major uncertainty concerning health risks. The efficiency of the OHS management in place is uncertain.

Streekstra under the name; Business Europe represented the Dutch employers’ organisation - VNO/NCW. He summarised the activities of the working group Risks of Nanotechnology, a Platform on Risk management of Nanotechnology, initiated by industry. Additionally, there is the Dutch SER (Social Economic Council) report Nanoparticles at the Workplace (2009). The Dutch deliberative platform between TU’s, NGO’s, industry and the government works as a good instrument (a reflection of the so-called “Polder-model”). In the first week of April 2009, the SER-advice on how to deal with nano at the workplace was presented to the Minister of Social Affairs. Streekstra stated that according to this document there is no need for an additional code of conduct, since the current EU and national legislation handles the risks properly: present legislation is sufficient to deal with nanotechnological risks.

Barry emphasized that the debate on the development of new technologies was ongoing for 10 years. The two main issues were that the Trade Unions did not want a second asbestos scandal. There was the absolute need for data in order that workers were informed of the risks of nanomaterials and their use in the workplace.

Musu stated that his opinion is in line with Cremers. It would be most important to tackle the legislative issues in the EU. At present there are many shortcomings and loopholes that should be resolved. He opined that health & safety should become an integral part of all research projects.

Streekstra reacted that this has been discussed in the Netherlands. At present the situation is that industry does invest in health & safety for all their projects. The question is, should this combination of technical and risk research be done in all cases, and if so, how or in what way? As there are many

10 Proceedings European Conference „Working and Living with Nanomaterials” NanoCap/STOA, 2 April 2009 different types of research, different materials and applications. From a company perspective it would not be reasonable to allocate a fixed percentage to the health & safety investments per project. On the contrary, this should be defined project-specific.

Angelidis reacted that he is very open to an internal and external dialogue on this subject. Currently, there is a gap in the scientific knowledge related to the behaviour and characteristics of nanomaterials and products. However, much is already known. Gaps should be identified and a strategy should be developed to fill them. However, in every research project, health & safety should always be addressed in one way or another.

Musu added to this by stating that the TU`s position was that each research paper should contain a section which covers the identified health & safety issues related to the topic and the measures that have been taken to prevent possible risks.

Axel Singhofen, (Adviser for Health and Environment Policy, The Greens) reacted from the audience that there is a clear need to change legislation (ETUC statement), Cremers mentions similar needs. However, the Commission still states that the current legislation is sufficient. Question to Angelidis: is the Commission now going to revise its statement?

Angelidis: responded by stating that a health and safety strategy is essential. But he added that scientific evidence is needed for policy making. Until that is it the Chemical Agents Directive (CAD) that sets the frame – employers have the legal responsibility to deal with risks.

Streekstra: stated that we cannot wait for scientific evidence. According to him the precautionary principle is already applied in the form of the occupational hygiene strategy (in CAD). Possible exposure in the workplace is managed by working with nanomaterials in closed systems and by taking exposure measurements. Furthermore, there is a CoC in place on how to apply the precautionary principle. Main principle of companies is to do their best to eliminate risk. It was his opinion that the Dutch Code of Conduct works well.

Musu reacts that there is a loophole in the CAD (98/24/EC) (Chemical Agents Directive) that applies to all chemicals regardless of the quantity used. The primary obligation for employers is to perform a risk assessment in case a substance used at the workplace is identified to be hazardous. In the case were the hazard data are lacking, the substance will not be identified as a hazardous substance with the consequence that no risk assessment is performed and risk management measures are not put in place. An amendment of the CAD should be made to require employers to implement risk reduction measures when the hazards of (nano) substances used are still unknown. And as long as the hazard (and therefore the risk) is unknown, any exposure has to be avoided. This means, for example, to work with a closed system to minimize the risk. There are companies, though, that on a voluntary basis follow this precautionary behavior in a strict way.

Nemery put the following question to the panel: Is it OK to apply nanomaterials and not to know the hazards or not to know how to measure these hazards or how to detect them?

Angelidis responded to this question by stating that REACH can be interpreted differently. However, there is a focus on risks for workers. Very few substances are safe. There is a difference between the precautionary principle and the minimum occupational health & safety approach. Member States have the duty to take action to evaluate the significance of the measures taken to protect the workers against risks. It is important to recognize that on this topic there are big international differences.

Barry stated that there are a lot of difficulties with the enforcement of voluntary codes. In the case where a company fails to address the hazards of any substance because of their unknown effects and fails to apply the voluntary code of conduct in place, the results of such a position is at the very least vague. He stated that there was no penalty to be applied in such circumstances. It was his opinion that changes to legislation or amendments to existing legislation are necessary to protect workers.

Audience: The Canadian workers’ representative speaking from the audience highlighted the uniqueness of the European approach. He stated that the ongoing debate in Canada and North America does not include a debate between industry on the one hand and NGOs and TUs on the other. He stated that he didn’t believe that under the present circumstances, the arguments to develop

11 new legislation are not sufficient. The problem is known but as the extent of the problem is not clear, you cannot say that you do not need further legislation.

Streekstra reacted that regulation might help but would not be enough, and that it is more important to reach an agreement with NGO and TU to work on the future. Voluntary codes are therefore very important. Multinational companies use different standards, global standards are about to be reached. SMEs are fully aware of the issue, but have no knowledge; they need to be helped by providing information to them. It is not an asbestos era anymore, multinationals have different attitude these days. The expectation is, though, that not all industry will follow the CoC.

Cremers was sceptical; most of the time people are really sceptical about soft laws (i.e. voluntary code of conducts)

Audience: Ulrik Spannow (Danish Construction Workers Trade Union) stated that the EU approach is well appreciated: the current status is that workers do not know, employers do not know and enforcers do not know much about in which products nanomaterials might be contained, and what protection measures to take. So we need action now! How to urge the member states to draw up action plans in the field of nanotechnology at workplaces? Just to make sure that directives are given on the national level until we wait for the European solution.

Barry replied by stating that, at the average workplace, nano is unknown and that there should be a health & safety strategy for the workplace. It is a question of awareness. What is it? How to deal with it? It is important to have a position on it.

Angelidis replied that there is already some knowledge on nano, but it is still not enough. More research is needed to gather information. For this, an open dialogue with the stakeholders is necessary, in order to have a proper new action plan for 2010-2015.

Streekstra reacted that the logical place is to communicate nano in the Material Safety Data Sheets (especially concerning the size specification). It is difficult to discern the complete supply chain due to the global trade. That’s why it is important not to have different systems between Member States, so we suggest that REACH, covering the whole European level, provides a good starting point

Audience: In order to apply the precautionary principle (PP), more knowledge would be needed, since how to know whether the application of the PP were necessary?

Angelidis stated that a focus on the minimum requirements is more efficient.

Musu explained that REACH is based on the precautionary principle. An example of how this principle should be applied in practice can be illustrated with dossier registration. Under REACH, producers have to register their substances prior to marketing to show that they can be used safely. When safety data are based on a test that is known to be inadequate for nanomaterials, this information should be considered as missing and the registration dossier incomplete. As a consequence, the producer should not be allowed to market its substance until the registration dossier is completed. This will also be an incentive for adequate nano-safety tests to be developed.

Audience suggested: only permitting the use of closed systems: would that be feasible?

Streekstra replied that production of nanomaterials “in general” takes place in closed systems; application of nanoproducts is normally not in closed systems. The risks appearing in the product chain have to be thoroughly studied, since implementing conditions comparable to a closed system along the whole production chain is impossible. Still each case is different. One should communicate to the workers that effective risk assessment and risk management are possible.

Musu confirmed that there are companies using closed systems. Safety data sheets need to be improved, and adapted to reflect the risks of nanoparticles, and additional training for employees is necessary.

Barry: The transfer of nanoparticles from the closed system to the open system is the key problem. Here expertise is needed. This might be done through the chemical safety report as set out in REACH.

12 Proceedings European Conference „Working and Living with Nanomaterials” NanoCap/STOA, 2 April 2009

Audience: How about the comparison of Nano to GMO?

Angelidis stated that nano and GMO are not well comparable. However, what they do have in common is that labelling is an issue, which could be an instrument useful for differentiation.

Audience: According to the adagio no data Æ no market, regulation is of no great use. France and the United Kingdom are currently developing regulation to allow production of CNT only in closed environments. Standardising is an interesting instrument.

Streekstra confirmed that there is a lot of discussion ongoing on standards for nano.

Angelidis emphasized that the determination and definition of nanoparticles and materials is needed first.

Audience: Obligation cannot be fulfilled. In the absence of a proper risk assessment method, legislation acts blindly. BUT workers have to be protected.

Audience (Health Ministry France): What is the commission’s response on standardization of carbon nanotubes? Is a Code of Conduct a useful tool in this respect?

Angelidis: It is necessary to have a full agreement on definitions before taking action.

Nemery: Will this conference speed up the process?

Angelidis: Since it is a multidisciplinary question, this conference cannot be the only necessary input.

Streekstra: This conference helps in many ways to speed up the process!

Nemery: The departments of universities also need instil the health and safety issue. Researchers of the academy in terms of education have the duty to talk about these issues upstream. At the same time patents should not be accepted unless there is something that tells something about the safety of production an development of these new materials. Sometimes we do not need precautionary principle. just elementary prevention principle, since there are already some risks we already know already, and precautionary principle is necessary only for unknown risk. They made to be very reactive, to have different biological effect, but prevention is enough, no necessary need for precautionary principle.

8. Environmental NGOs position, perspectives and discussion John Hontelez (Secretary General of the European Environmental Bureau)

Hontelez presented the common views and positions of five NGOs involved in the NanoCAP project, Baltic Environmental Forum, EEB, LEGAMBIENTE, MIO-ECSDE, and Natuur en Milieu. The main message of the NGOs is: There is an urgent need for sustainable and responsible governance of the development and use of nanotechnologies, covering both nanomaterials and nanoproducts, at national and EU level. Nanotechnologies promise to bring improvement in many sectors: healthcare, environment, energy, electronics. However, as yet only limited societal benefits have been brought about by most of the commercially available products currently on the market. The optimistic expectations on the benefits of nanomaterials may in some cases prove to be true. Thus, a strict regulatory framework, based on the precautionary and producer responsibility principles, should be adopted in order to ensure that these nanomaterials are developed and used, and that they are not posing threats to the environment and human health through their entire lifecycle.

Policy and regulation issue NGO demand 1. Existing legislation needs to be amended, to address nanomaterials more explicitly and comprehensively, and it needs to be reinforced to ensure safety to human health and the environment as envisioned in existing laws.

13 2. Development of a regulatory and policy framework for existing and future nanomaterials. 3. Implemenmt the “no data Æ no market” principle in the real world. No further market introduction should be allowed for products containing manufactured nanomaterials until appropriate impact and safety assessment tests have been developed. 4. A clear, harmonised and internationally accepted definition of nano-technologies and nanomaterials should be adopted to avoid inconsistencies in risk governance and enhance the applicability of existing and future legal frameworks. 5. Nanomaterials as a whole should be defined, treated and labelled as a new class of substances. 6. Develop a pre-market registration and approval framework. 7. Guarantee transparency, traceability and provision of information to consumers through information on products that contain nanomaterials. 8. Full lifecycle analysis including environmental, health, and safety impacts must be performed prior to commercialisation. 9. Current voluntary codes for the safe development and the responsible use of nanoscaled materials should become mandatory.

Research and Development NGO demand 1. Nano-research and development should be driven by real societal needs and based on ecological, social and sustainable development considerations, but not on the ‘marketability’ of products. 2. Clearly identify the limitations of existing safety assessment and management tools in relation to nanomaterials. 3. In particular, there is an urgent need for additional toxicological and ecotoxicological studies, tests and protocols in order to assess health and environmental impacts. 4. All new nano-related projects receiving EU funding should be required to include a sustainability assessment and appropriate decision making mechanisms, including public participation. 5. A research strategy identifying a roadmap towards the safer development and use of nanomaterials in their different applications should be developed and implemented. 6. Sustainability assessment of (new) technologies tools should be developed, for their more systematic use in both research and product development.

Public awareness, Public participation & Decision making NGO demand 1. Transparent and effective communication of the risks of nanotechnologies to society is needed. 2. Environmental NGOs urge the European Commission and the Member States to immediately undertake an EU-wide public debate on nanotechnologies and nanomaterials.

Developing countries & countries with emerging economies – NGO demand 1. There is a need to place nanotechnologies and nanomaterials use in the context of development and employ these to meet internationally agreed poverty reduction goals, such as the Millennium Development Goals. 2. Assure that no new risks to environment and health are created in developing countries as a potential dumping ground for nano waste or as an “easy”, not strictly regulated market. 3. Nanoproducts should not become expensive alternatives to existing effective local technologies, e.g. in water treatment. 4. Nanoproducts should not substitute the products traditionally produced by developing countries. 5. Attention should be paid to specific risks that might affect developing countries due to their particular environmental and social conditions. 6. Partnerships should be established in order to assist developing countries or countries with economies in transition to build scientific, technical, legal and regulatory policy expertise related to risks of manufactured nanomaterials. Clearly, much more work is needed on EU policy level to improve environmental and human health protection and to build governance structures based on the premise of public participation in decision- making, the precautionary principle and cradle-to-cradle product sustainability when addressing nano- and new technologies.

14 Proceedings European Conference „Working and Living with Nanomaterials” NanoCap/STOA, 2 April 2009

9. Nano and the environment debate - Panel discussion Panel : Dragomira Raeva (EEB), Laura Degallaix (BEUC), Lena Perenius (CEFIC), Carl Schlyter (MEP), Henrik Laursen (European Commission DG Environment), Lucas Reijnders (University of Amsterdam) Chair: René von Schomberg (European Commission DG Research)

SUMMARY OF THE DEBATE

The panel discussion focused on the following issues with respect to nanomaterials: risks assessment and management, regulatory requirements, and transparency of the market.

Risk assessment and management Discussing the different aspects of risk management and the application of the “no data, no market principle”, some panellists pointed out that there are extensive data for some nanoparticles already (i.e.TiO2 and SiO2) including on the impact of airborne exposure on human health. It would be relatively easy to derive limits for exposure based on currently available information and already regulate for some nanoparticles. The lack of risk assessment methods for nanoparticles is not seen as a limitation by policy makers. There is already an initiative at OECD level on investigating the applicability of existing risk assessment methods to nanoparticles. In principle the tools to assess the risks are available, the Commission stated, the challenge is to make these operational for nanomaterials. Risk acceptability was challenged by the environmental NGOs. They claimed that the precautionary principle should apply when data are insufficient before the discussion on risk acceptability. Acceptability should in any case be decided by public debate. This was done for GMOs, and can be repeated for nanomaterials. In any case, risk communication tools should be applied ensuring timely communication with the public and all concerned stakeholders. Acceptability is also linked to a discussion on which products containing nanomaterials are “good products”. Consumer groups made it clear that a good product is on the first place safe for the environment and human health. At least for cosmetics and foods there cannot be acceptance of risks that can be easily avoided by using nano-free products. Industry representatives insisted that risks and benefits need to be reviewed jointly, especially when considering the application of nanomaterials in green/ clean technology, such as in water purification.

Regulatory aspects During a discussion on the mandatory registration of products containing nanoparticles, a European Parliament representative confirmed that this is the way to go until REACH is fully adapted to cover the registration of nano materials. Consumer groups backed up this position by highlighting that mandatory registration by industry would help gather public data on safety and toxicity. Industry however, opposed this view, claiming nanoparticles can already be dealt with within REACH, ensuring that about 80% of nanoparticles currently on the market will go into the first phase of REACH, before 2010. CEFIC also agreed that REACH will not cover everything and that the assessment methodology is not yet fully in place, b nevertheless existing methods are applicable, with some modifications. The mandatory registration of products sounded unappealing to industry though, with no clear benefits it would generate in addition to REACH registration of materials.

DEBATE

Von Schomberg: The panel discussion will focus on the following issues: risks, regulatory requirements, and transparency of the market. The first issue will be risks: the statement ‘no data Æ no market’ is often cited regarding nanomaterials. What does that mean? Do we have data and are they adequate?

Reijnders: We already know a lot. There are extensive data for some nanoparticles, especially TiO2 and SiO2. Also there are data regarding the impact of airborne exposure on health. It would be relatively easy to derive limits for exposure based on what we know from research into particulate matter. We could already regulate for titanium and siliceous nanoparticles. It is strange that we have not done that yet. We also know a lot about certain applications, such as sunscreens. The risks to human health are linked to the photo-catalytic effect of the particles. Complete coating of these particles should be made mandatory. We can also regulate by analogy. We know that bacteria develop a resistance to antibiotics if they are regularly exposed to them. We could apply this

15 knowledge to limit the use of nano-silver, so that it remains effective in treating infection in burns. There is also an analogy between nanotubes and asbestos.

Von Schomberg: There are no risk assessment methods for nanoparticles. What does that mean for legislation in Europe?

Laursen: We are not starting from scratch. The OECD is investigating the applicability of existing methods. Some apply to nanoparticles, some don’t. We have tools to assess the risks of many nanoparticles. The challenge will be to bring all the information together and make it operational. More work is needed but we have a good base to start from.

Von Schomberg: Once we have assessed the risks, how do we decide whether these risks are acceptable or not?

Raeva: We should apply the precautionary principle when data are insufficient. This comes before a discussion on which risks are acceptable. Acceptability should be decided by public debate. This was done for GMOs, it could be repeated. And consequently: no data Æ no market.

Question from the audience: We are already in the nano-world. Is the precautionary principle still relevant, or has its moment passed? There are worries in North Africa about the risks. REACH should be adapted to deal with nanomaterials quickly.

Von Schomberg : Is REACH based on the precautionary principle?

Laursen: The precautionary principle is set in the EU Treaty. REACH refers to it. Currently, there are 2.7 million pre-registered substances. It is difficult to say how the precautionary principle will be applied without having a concrete case.

Von Schomberg : Should risk assessment be mandatory?

Laursen: There is a difference between risk assessment and risk management. In absence of data, decisions will have to be made using – among other things – the precautionary principle.

Von Schomberg: Should there be mandatory registration of products containing nanoparticles? What is the opinion of the European Parliament?

Schlyter: A recent vote in the Environment Committee called for a public inventory of all products containing nanoparticles. This is not the same as applying the precautionary principle. REACH is not yet suited to deal with nanoparticles. The Environment Committee also voted to close the loopholes in REACH in the next two years.

Von Schomberg : Would mandatory registration work for companies?

Perenius: REACH is one of the most comprehensive chemical regulations in the world. It can already deal with nanoparticles: they can be registered at the same time as the bulk version of the same substance. In that way, 80% of nanoparticles currently on the market will go into the first phase of REACH, before 2010. REACH will not cover everything and indeed the assessment methodology is not yet fully in place. But existing methods are applicable, with some modifications. The industry wants to listen and take account of the concerns of stakeholders. We have to come to a shared vision of sustainable development. As to mandatory registration: what would be its purpose? What benefits would it generate in addition to REACH?

Degallaix: It is disappointing that consumer organisations were not included in the NanoCap project. There is a lot of concern about the potential effects of nanoparticles. Transparency about the uses of nanoparticles is necessary to assess exposure of consumers/citizens and the environment. Therefore we need mandatory notification by industry. Also the data on safety and toxicity need to be made accessible to the public. The Commission needs to ensure transparency to also allow for market surveillance, risk assessment and the withdrawal of products.

16 Proceedings European Conference „Working and Living with Nanomaterials” NanoCap/STOA, 2 April 2009

Question from the audience: In France there is concern about carbon nanotubes and their similarities to asbestos. Should we wait until REACH is completed in 2018 or should we take measures before that? Also it is necessary to develop nomenclature to properly manage the risks of nanoparticles. We have to be able to distinguish between different forms of the same nanoparticle.

Laursen: The development of a thorough nomenclature takes time. In the interim we will have to work with the vocabulary at hand

Degallaix: In France an inventory of products containing nanoparticles is under preparation. This will be a very useful tool that will help us evaluate the level of exposure. Labelling requirements for consumer products containing nanoparticles with which consumers come in direct or regular contact (e.g. cosmetics, food products) need to be imposed while an EU-wide inventory of nanoparticles- containing products is being developed. Such requirements could be to indicate the word ‘nano’ next to the name of an ingredient in the ingredients’ list on food products as it will soon be required on cosmetic products according to the new regulation.

Reijnders: We need to speed up the process of data-flow. It takes a lot of time before research data reach the people who actually work with the products.

Perenius: Transparency is the cornerstone of the CEFIC strategy for responsible nanotechnology. The chemical industry sells mainly to business. Safety data sheets are required there; in REACH extended data sheets will eventually be introduced. Some companies already invest in educating both their workers and their customers.

Schlyter: It is good that industry is now working for transparency. This was not the case when REACH was being developed. This change of mood is helpful. Parliamentarians have a responsibility for what is allowed onto the market: it should be safe. This guarantee cannot yet be given for nanoparticles.

Question from the audience: In their presentation, the NGOs did not address the benefits of nanotechnology. The discussion focuses on the risks. The environmental benefits of nanotechnology in general should be taken into account, not just the risks of nanoparticles.

Raeva: EEB has developed a brochure listing potential benefits of nanomaterials. The NGO movement is not blind to the opportunities, but also not blind to the risks.

Question from the audience: In Tunisia the discussion on nanotechnology and its possible risks is limited to a very small circle. However, it brings back memories of mad cow disease and asbestos. Is there a technology transfer programme in the EU? Is attention being given to the implications of nanotechnology for global sustainable development and the gap between developed and developing countries?

Von Schomberg: The EU favours research that is driven by society when it comes to the millennium goals.

Question from the audience: ‘Responsible’ appears to be the new sexy adjective. It hides power relationships and conflicting interests. How responsible is responsible, if different actors have different definitions?

Von Schomberg : The Code of Conduct outlines a programme to promote responsibility. It is not just a question of enforcing, but of enabling, inviting, and persuading. The basic question is which actors will take up responsibility. There is a positive response to the Code of Conduct from industry and NGOs. The Member States are hesitant. Perhaps the European Parliament can help there.

Schlyter: Responsibility expresses a feeling. The European Parliament gives it meaning in its report. It also gives directions how to translate responsibility into legislation.

Von Schomberg: The issue of benefits was raised. What is currently on the market is not very exciting. What would be a good nano-product?

17 Degallaix: First we need to know which nanoparticles are safe. There is as yet no proof of the benefits (nor of the safety) of nanoparticles in products. So it is impossible to say what a good nanoproduct would be. In medicine there definitely will need to be a weighing of benefits and risks, but cosmetics and foods should be safe. There should be no acceptance of risks in cosmetics and foods. A good nanoproduct is a product that is shown to be safe without any compromise on its safety.

Laursen: Benefits should not be a pretext to accept risks that can be easily avoided. Safety first, to make benefits possible.

Perenius: Risks and benefits need to be reviewed jointly. But clean technology is needed, for example cheap, safe water purification. That would be a good nanoproduct.

Question from the audience: The Nanoforum in France wants to initiate a stakeholder dialogue but finds it difficult to get companies to take part. Maybe this situation is better in other countries?

Perenius: It can be difficult to get a dialogue going. CEFIC will give the right information to the right audience in the right way. Industry needs to be in dialogue with stakeholders and take seriously what is being learned in the process.

Question from the audience: There is need for the general public for easy understanding of information. Next to mandatory reporting, there should also be ordinary reporting.

Degallaix: The public needs to be engaged in decision making. Risk communication tools should be applied. Consumers need the facts, and need to know about uncertainties.

Question from the audience: Do environmental NGOs have a suggestion which percentage of the research budget should be spent on safety, health and environment?

Reijnders: Currently, only a relatively small amount of money goes to risk research, probably no more than 5%. The NanoCap project wants to have this raised.

Von Schomberg: currently risk research is 7-8% of the budget under the EU Framework Programme. In FP7 there is 3.5 billion euro for nanoresearch. There is the need to spend that money wisely, also when it is applied to risk research.

Raeva: The EEB wants to increase the budget for risk research. Public participation and involvement in setting research priorities is essential.

Laursen: The Commission is engaged in dialogue with industry, NGOs and trade partners outside the EU. REACH has changed the burden of proof: now the producer has to prove that his product is safe. This should not be reversed in the case of nanotechnology, putting the burden of proof for safety on public authorities.

10. Conference Conclusions Alfred Nordmann (TU Darmstadt)

Background • The nanotechnology ethics portfolio (as written during the course of the NanoCap project) is work in process that will continue within and grow beyond NanoCap. • What is needed is not a list of ethical concerns that are presented by well-meaning and sensitive or aware individuals but a representation of vital interests in the face of a new way of doing things. Such new ways are needed, since traditional precautionary and regulatory attitudes unwittingly imply a moratorium, and that is definitely not considered to be the preferred state. The message of nano: It can’t wait for scientific evidence of safety or harm (which may never become available). And if for precautionary reasons all possibly nanoparticles emitting applications would have to be contained in close systems, it won’t flourish in the market.

18 Proceedings European Conference „Working and Living with Nanomaterials” NanoCap/STOA, 2 April 2009

The conference had two significant dimensions: • Within the existing framework of “responsible development of nanotechnologies by all stakeholders” the trade unions and NGOs highlighted and specified their genuine points of contention and decision making (e.g. regarding REACH) • Beyond this, their powerful social involvement raises the stakes for political, deliberative negotiations on nanotechnologies.

Learning process: 1. Adapt the realities of nano (for now especially: nanoparticles) to regulatory expectations, safety concerns, precautionary approaches. 2. Develop new strategies and criteria for “responsible development” which soften the regulatory demands and yet do not fail us in the end. This is a learning process for European knowledge societies and within NanoCap.

Strategies at work today: 1. Responsible (sustainable) development: Including codes of conduct, observatories, public engagement, ELSI-research (Ethical, Legal and Social Issues). 2. Precaution: to see how far we can go without producing a moratorium. If we do not know that a substance is hazardous, let’s treat it as if it were; preference on closed systems 3. Spirit of “collective experimentation” – anxiety and euphoria. Toxicologists advertises knowledge gaps, economists don’t, and their optimism about nano feeds the hopes of everyone.

• All today’s discussants engaged in the tentative and careful balancing of unknown risks and unknown benefits. E.g. everyone agrees to “no data Æ no market”, but it is difficult to tune differences of interpretation into clear-cut decision items. • Concerted vigilance proceeds in the mode of conversation and mutual learning from all stakeholders, but there were hints today of stronger political deliberative moments and possibilities.

Deliberation beyond conversation: 1. Social movements assembled at the conference: stakeholders defined as advocates rather than being reduced to concerned individuals. 2. Injecting hard principles into soft law – social movements have the power to unilaterally apply the missing sanctions to the voluntary codes. 4. (No-) nonsense products and projects: the ensured societal benefit of nano is still missing. (missing agenda and research priorities)

11. Closing remarks Mrs Dorette Corbey, MEP

It was a very encouraging event. I picked up a number of political points: • A good legal framework is needed to manage the possible risks associated with nanotechnology. A legally binding framework is better than a voluntary one. Voluntary approaches work well in some countries, but not in others. This framework should include risk assessment. • Communication is important. Labelling of products is only a first step. Consumers need to know more. The role of technology needs to be assessed. Technology can cause alienation and this could also apply to nanotechnology: it could alienate people from the products they use, from their houses, from their environment. Communication could help here. • Who is in control? Is it business, science, governments, NGOs? NGO’s definitely should be empowered to share control. What about the general public? NGOs not always represent the ordinary citizens. Techniques need to be developed to involve the public in decision-making. The mistakes made during the GMO discussion need to be avoided.

Brussels/Amsterdam 28/7/09

19

ANNEX I: PowerPoint presentations

NanoCap Nanotechnology Capacity Building NGO’s

FP6 Project, Science & Society programme

Introduction to the NanoCap project Capacity building project for trade unions and environmental NGOs Working conferences, positioning discussions, workplace visits ƒ Technical issues NanoCap conference ƒ Environmental issues Working and Living with Nanotechnologies ƒ Occupational health and safety issues ƒ Ethical issues ƒ Critical assessment of benefits Thursday 2 April 2009 European parliament, Brussels Contribution to public nanodialogue Pieter van Broekhuizen ƒ Discussion with members, authorities, industry and the public IVAM UvA BV Amsterdam Period ƒ September 2006 – September 2009

NanoCap coordinationcoordination Environmental NGOs

MIO - network countries Trade Unions

1 Universities TUs and NGOs in the nanodiscussion

ƒ The capacity building of NanoCap was successful to support TUs and NGOs developing their nano-positioning ƒ The knowledge increase did not result in an increased aversion against nanotechnologies ƒ Both were able to develop collective European position statements, sometimes complemented with national refinements ƒ The TU and NGO positioning do not converge much ƒ The precautionary approach plays a key role in both positionings

What we learned in NanoCap Workers’ interests in nanotechnologies many questions….. ƒ Safe workplace ƒ Transparent and independent risk assessment Difficulties in rrecogniecognizzinging nanoproducts ƒ Precautionary approach in case of lacking data ƒ • Who are the nanoproduct manufacturers ? ƒ Full compliance with legislation • Who are the professional users? NGOs interests in nanotechnologies • What i s nano i n th e prod uct ? * • Where are the nanoproducts ? ƒ Sustainable technologies and safe products ƒ Non-disperse use of nanoparticles ƒ Difficulties in judging the benefits ƒ Precautionary approach in case of lacking data • Are the benefits really benefits? (LCA) ƒ Full compliance with legislation • Nonsense or no-nonsense produts? ƒ No nonsense products

Nano or not nano ? The nanonano--underunder pants…. With use of an innovative technological process originating from NANO-technology …..softer …. optimal absorption….

Rijksmuseum Amsterdam

2 What we learned in NanoCap Some examples many questions….. of questionable benefits

ƒ Difficulties in rrecogniecognizzinging nanoproducts ƒ Self cleaning roof tiles: • Who are the nanoproduct manufacturers ? What if a bird shits on the TiO2 –UV • Who are the professional users? catalysed coating…….? • What i s nano i n th e prod uct ? * selfcl eani ng or non-cli?leaning? • Where are the nanoproducts ? ƒ Car glass treatment: water repellant and….. helps save you money, too, by cutting down on ƒ Difficulties in judging the benefits windshield wiper replacements and the amount of • Are the benefits really benefits (life cycle approach) • Nonsense or no-nonsense produts? washer fluid used……… durability after abrasion and a few rains……..? and what about environmental pollution…..?

Some other examples Nonsense or nono--nonsensenonsense ?

ƒ AntiAnti--odorodor and anti-anti-bacteriabacteria socks Real benefits For healthy feet….. Wellbeing from pure silver Other non-sterilizing anti-smelling options ………? or the Emperor’s ƒ Bactericidal walls for surgery room new (nano) Prevention of accidental infections……? cloths

ƒ Car exhaust NOx converting road asphalts ?

- Efficiency in NOxÆ NO3 ….?

Environmental TiO2 pollution….?

Balancing nano risks and claimed benefits Economic value Health & ? Environmental risks Claimed benefits NanoTech Index Hazard Exposure Scarcity Stakeholder Behaviour interests Emotion Uncertainty Job perspective

“Acceptable” Opportunistic uncertainties value

Policy Rijksmuseum Amsterdam

3 Taking the precautionary Consequence of accepting a approach seriously precautionary approach 1

Essentials ƒ Operationalising the precautionary approach ƒ Ignorance of precaution: • Carrying out a social experiment, exposing society at large to • Practical useable set of measures NP and NT (quote Andrew Jamison) • Accept limited evidence as argument to take precautionary measures ƒ Insight in nano properties • Acceptance of the “risk” that with growing evidence initial • Intended technical effect may (will) affect organisms in a preventive measures might have been chosen too strict similar way • Inform about what you know and what you don’t know ƒ Incorporate uncertainties in R&D, introduction and use of • Comprehensible info for users of NP and NT nanotechnologies • Transparent deliberations • in risk assessment and - management • in economical forecasts • in social and ethical aspects

Consequence of accepting a Building blocks for a precautionary nano approach precautionary approach 2 ƒ No data Æ no exposure ƒ Notification nano product composition for manufacturers and suppliers 1. Declaration of type and amount of NP in the product to an independent body ƒ Conditions for acceptance of Code of Conducts 2. Declaration of nano-content of product through the production chain • Organizing a more binding status ƒ Exposure registration for the workplace • External monitoring of compliance 1. Analoggggue to carcinogenics registration for nano-fibres and CCSMRS–nanomaterials 2. Analogue to reprotox registration for other non-soluble nanomaterials • Call for a safety notice to be included with all journal publications (just reporting what precautionary measures ƒ Transparent risk communication did the researchers actually take) 1. Information on MSDS on known nano-risks, management and knowledge gaps 2. Demand a Chemical Safety Report (REACH) for substances >1 ton/year/company • Call for a uniform European CoC for industrial production ƒ Derivation of nano-nano-OELs,OELs, nano reference values* (Prevent an unlimited proliferation of different CoCs) 1. fullerenes, SMCNT, MWCNT, Carbon Black, nano- polystyrene and dendrimers 2. Ag, Fe, TiO2, CeO2, ZnO, (amorphous)SiO2, alumina, nanoclay ƒ Development of an early warning system ƒ Measures to avoid marketing of “non“non--sense”productssense”products

Proposed nano reference values (benchmark exposure levels*) Benchmark Cat Description Remarks levels

1 Fibrous, insolublinsolublee NM 0,01 fibre/ml In analogy with asbestos

NM CMRS in its NM potential increased 2 molecular or larger 001xOEL,1 x OEL dissolving rate form Safety factor 0,1 In analogy with NIOSH (2005) Insoluble or poorly OEL / 15 Increased surface Æ soluble NM (not 3 increased reactivity covered under i or ii SF = 1 / 15 (x 0,066) Soluble nanomaterials 4 0,5 x OEL SF = 0,5 (non i-i-iii)iii) Thank you for your attention * As proposed by BSI (2007)

4 Governance and Ethics of Nanotechnologies under Overview of this Presentation the Science in Society programme of the EU’s Framework Programme for Research

1. Evolvement of Ethics & Governance of Nanosciences and Nanotechnologies under the Science in Society Programme: What is at Stake?

European Commission 2. Prospective issues Research DG

Head of Unit Governance and Ethics, 3. European Commission policies and commitments Pēteris ZILGALVIS, J.D.

NANOTECHNOLOGY. WHAT IS AT LESSONS FROM THE GMO DEBATE STAKE? • Ethical acceptability of technology • Early intervention of society in RTD Stage • Early identification of benefits and risks • Early involvement of all stakeholders • European and international research cooperation and governance • Creating regulatory oversight and certainty

(PROSPECTIVE/CURRENT) ETHICAL NANOTECH IS DIVERSE ISSUES Human Health Nanomedicine • Human enhancement- ICT brain implants, augmentation of senses, retardation of ageing Detectors/surveillance Security • Predicitive Nanomedicine: growing gap between diagnosis and possible therapy Environment Safety • Surveillance and Detection: Balance between privacy and security

1 (PROSPECTIVE) CURRENT RISK CHALLENGES ISSUES

• Involving civil society actors in nanotech • Safety, Ethics, Research on Risks research: Project NANOCAP provides an example! • Application of Precautionary Principle • Acceptability of Technology: product benefits and product safety are crucial • Implementing the Code of Conduct • Map governance and ethics issues at EU and international levels • EC is committed to Public Debate

EC recommends Member States European Commission policies

• Adoption of European Strategy for – CoC to be used as an instrument to Nanotechnology (May 2004) and Action Plan (June 2005) emphasizing the need for a encourage dialogue at all governance levels “safe, integrated and responsible amonggp polic y makers, researchers, industr y, development of N&N. ethics committees, civil society organisations • Announcement of adoption of Code of and society at large Conduct at international level –Inform the EC by February 2010 • Implementation of International Dialogue, but –Cooperate with EC to monitor and review failed to adopt a CoC Code biannually

NANOCAP

• NANOCAP enabled CSO’s to elaborate views and thus contributes to informed public debate • NANOCAP results can feed into ongoing multi-stakeholder dialogues • Early example of a more deliberative approach of RTD research policy • No debate-fatique: today is an example: Congratulations

2 European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment)

STOA Rules - Mission Nanotechnologies - Assessment Article 1(2): “… STOA shall: of Technological Potential and − provide Parliament’s … parliamentary bodies … with independent, high-quality and scientifically impartial studies … for the Policy Implications: a STOA assessment of the impact of possibly introducing or promoting new technologies and shall identify … the options for the best courses Perspective of action to take …” Article 1(3): “ STOA shall carry out its work in such a way that the results are relevant to the European Parliament in its role as Paula Hernández, dr. Miklós Györffi, legislator.” Policy Department A: Economic and Scientific Policy Article 1(4): “STOA’s work shall have long-term objectives and it DG Internal Policies, European Parliament shall differ from the work of the Secretariat’s research departments, the task of which is to meet specific sectoral or short- term requirements”.

Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) The STOA profile STOA Rules - Studies of Technology Assessment (Article 6) • STOA work is focused on the scientific assessment of the impact of new technologies and identification of policy options relevant to Parliament's role as legislator. • Studies of technology assessment should provide an answer to medium- to long-term, complex and interdisciplinary problems • STOA projects address medium to long-term issues and are relatinggp to the impact of scientific and technolog ical distinct from the projects financed from the expertise budgets of developments on society. committees. • The proposals submitted for that purpose are approved by the • STOA maintains contacts and cooperation with other STOA Panel on the basis of the following criteria: parliamentary technology assessment bodies, in particular with – relevance of the subject to Parliament's work, scientific and members of the EPTA (European Parliamentary Technology technological nature of the proposal, and Assessment) network. – availability of scientific evidence covering the subject. • STOA establishes links with the scientific community, as well as with society at large, as the recipient of the consequences of science and technology policy.

Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Recent STOA activities linked to ? Nanotechnologies Projects: • Technology Assessment (TA) on Converging Technologies (viWTA) MEP(s) • The Role of Nanotechnology (NT) in Chemical Substitution (ITAS) • Nanotechnology - Threat or Opportunity ? Workshop in the EP, 5 March Study 2008 (Karita Research) • Future: Nanosaffyety External STOA STOA Links with the scientific community, as well as with society at large: Expertise • Collaboration with the European Commission: Workshops – European Forum on Nanosciences - 19-20 October 2006, - Nanocafé - Will Interviews Nanosciences Shape Future Society and How Will Citizens Benefit from it ? - Nanologue Project • Participation in external events: MEP(s) – Roundtable “The Ethical Aspects of Nanomedicine”, 21 March 2006, Brussels – Conference “Nanotechnology – Products and Processes for Environmental Benefit”, 16 – 17 May 2007, Royal Society, London

Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

1 European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment)

Nanoscience, Nanotechnology & Nanomaterials Political questions

Nanomaterial NNNNanomaterial Origin Workshop held in the EP in Brussels on June 27, 2006 based on the literature • external dimension(s), or an study and vision assessment internal structure, on the nanoscale Nanoscience • novel characteristics compared to Natural the same material without •Caracteristics Nanoparticle Dorette Corbey, MEP, member of the STOA Panel: nanoscale features

ano •Behaviour chnologies

N Purpose-based definitions • Who is in control? Nano-object e according to the context in which Nanotechnology Engineered • What are the values of converging technologies and what is the it is intended to be used •Design • nanoscience •Measurement Nanostructure impact on society? Who benefits? • research and development (nanotechnology) • Where are converging technologies headed ? Is countervailing power • industry Industry Nanoparticulate possible? • risk-related regulatory framework, •Production matter Definitions for for Definitions • standardisation purposes methods • Popular support: are Newbic's applied in the service of humanity ? •Production mechanism How can we organize the debate arena? TA on Converging T on Converging TA Purpose map for nanoscale Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Public Debate on NBIC convergence Literature Study - Objective Scenario Heaven (US) Hell (US) Prevail (EU)

Development TechnologyEric Drexler develops (1986) exponentiallyBill Joy (2000) • Three perspectives on NBIC convergence: technology Ray Kurzweil (1999) Francis Fukuyama (2002) Antón et al. (2001) People Gregory Stock (2002) RAND Technology determines historyBill McKibben (technological (2003) Human behaviour – Historical Determining Roco & Bainbridge Alfred Nordmann determinism)(2002a) - NSF-report President´s Council determines the direction of factor & on Bioethics (2003) (2004) – Converging Converging technologicalTechnologies development – Overview of the public debate risen in the past few years Technologies for Susan Greenfield

chnologies chnologies Shaping the future of Parties (2003) ((gtechnological e e iihimproving human constructivismEuropean Societies/co-evolution performance ETC Group (2003) – Technological Martin Rees (2003) technology and society) Outcome Progress Disasters and Outcome co-evolution • Provide an accessible and well-informed basis for the discussion on the technological catastrophes technology and society is principally uncertain social impact of nano, bio, info and cogno sciences (NBIC) convergence development Development Human nature is Technology changes the Belief in moral progress and • Informing policy makers and politicians about how the public and humankind ‘under construction’ principle characteristics growth of communication Intelligent machines of human nature between people under the political debate on NBIC convergence is developing and what role they (Übermensch) win the Humans as a species are influence of technology evolutionary struggle threatened by technology can play in this upcoming discussion with humans TA on Converging T on Converging TA T on Converging TA Ideology Transhumanism BioLuddism Down-to-earth

Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

BiologicalEuropean Parliament, computer DG Internal Policies of the Union, DirectorateHuman-machine A: Economic andinteraction European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment)

Technological Perspective on NBIC convergence Trends in the convergence of nanotechnology Development of Scientific activity relative to 1999 • The4 first steps towards NBIC Cogno And biology convergence haveNano-ICT already • Many processes of biology takes place at exactly length scale than 3,5 Biotech-ICT nanotechnology

f been taken: laboratories, research department,CogSci-ICT • The convergence is occurring in two directions

ber o MatSci-ICT =1.0) 3 Image processing

chnologies chnologies – Nano to Bio Æ nanotools (microscopy and sensors) m 9

e conference, reports , e ICT Biotech – Bio to Nano Æbiological fabrication routes and biological materials as policy2,5 markers building blocks • NBIC convergence is And new materials and ICT expected2 to lead to a Nanotech & • 10% of the publications in the overlap area ICT-new materials are the same publications (199 publications

Relative growth nu growth Relative new paradigm (living and as the publications in the ICT-nanotechnology 1,5 NewExamples non-living materials and • Also similar convergence can be identified in: materials – Electronics and photonics in telecommunication systems)1 1999 2000 2001 2002 2003 – Simulation, modelling, image processing and pattern recognition, and TA on Converging T on Converging TA T on Converging TA neural networks Year

Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

2 European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment)

Literature Study - Conclusions NT in Chemical Substitution Transhumanist and BioLuddist Heaven and Hell Objective

Positive Negative • Determining the potential of NT for the substitution of Grab the attention of the media and policy Assumption of exponential development hazardous substances in chemistry makers and thus are effective in setting the and radical change • Identifying new applications of NT which could help to stitution

chnologies agenda b e reduce the ri iksks rel ltdtated to h azard ous sub btstances and ch emi cal Expose the most sensitive issues in the Danger that the political debate be debate and clarify the normative deep core dominated by extreme futuristic visions processes issues at stake that are speculative Questions addressed Focus currently on the most delicate issue: Emerging polarisation within the public • Which substances are considered as ‘hazardous chemicals’? human enhancement on the one hand and debate Preventing itÆAlternative technologies getting out of control and images of future • What is meant by the term NT and how can it be distinguished leading to huge societal catastrophes on the other from biology and chemistry respectively?

NBIC convergence is expected to push biopolitics central stage Down-to- in Su Chemical NT • What is the meaning of ‘chemical substitution’ in relation to TA on Converging T on Converging TA earth => Normative issue put forward NT? Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment)

Substances considered as Methodology ‘hazardous chemicals’

Only substances which are already known as toxic and dangerous -giving their views in the evaluation of preliminary to human and the environment were considered: Summary MEP’s findings. stitution stitution – Heavy metals b -relating policy options. b – Dirty dozens (most of them insecticides) 9 Persons Experts Workshop active in the – Brominated flame retardants on NT field of NT Focused on discussion among – Volatile organic solvents

– Toxic organic pollutants NT in Chemical in Su Chemical NT in Su Chemical NT

Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Substances considered as The meaning of the term NT and its ‘hazardous chemicals’ distinction from biology and chemistry • Prioritisation of hazardous substances • The term NT encompasses a wide range of tools, techniques and potential – Toxicity applications – Amount of material used • Political background definition of NT – Variety and amount of products containing these substances – There is still not universal definition of NT – Distribution of the products stitution stitution – NT was accomppygpanied by big promises and hug gpe expectations b – RlRelease of fth the sub btstance b y th e prod uct s b – Contact with humans • Technical definition of NT – Degree of existing regulations and agreements on the respective – Most of the definitions of NT comprise a further aspect: the nm-size substances structure must enable new functionalities • Nature of the application in which hazardous substances are – In practice the new functionality is often unclear or not even mentioned used. Genetic engineering could be attributed to NT – Closed system – Terms of size: Chemistry is not usually attributed to NT (< 0.001nm) – Semi-open system (0.1-100 nm) Nanosciences NT in Chemical in Su Chemical NT – Open system in Su Chemical NT Nanoelectronics

Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

3 European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) The meaning of the term NT and its The meaning of ‘chemical substitution’ distinction from biology and chemistry in relation to NT • Main characteristics of NT • Substitution is not restricted to the replacement – Diversity of a hazardous substance by a less or non- – Enabling Technology hazardous substance – Early stage of development stitution stitution b – Existence of a debate on NT b • NT prov ides new eff ect s whi ch are not b ased on • Definition of NT in this project chemical properties but on the physical – As a first approach, everything is considered as NT which is claimed properties caused by SIZE and SHAPE by proponents to be NT • NT can be used to developed completely • Publications from journals carrying ‘Nano’ different processes or different products which • All projects carrying ‘Nano’ in their title serve the same purpose but in completely NT in Chemical in Su Chemical NT • Publications and projects dealing with typical NT objects in Su Chemical NT different way

Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Findings Nanologue project www.nanologue.net

Materials Conclusions Call for a dialogue on Benefits: • Coatings • At present: NT can not contribute in an nanotechnologies •Enhanced mechanical properties • Flame retardants exceptional manner to a large increase of •Large surface/interface •Adjustable property • Flexibiliser substitution of hazardous substances How will citizens benefit • Substitution or • For the future: NT has a considerable potential •Ultra-precise surfaces Reduction of for substitution from NT ? ... •Antibacterial / biocompatible stitution anosciences b solvents • For a comprehensive assessment, each identified •Coating…In the future possibly: • Catalysts example has to be assessed case by case and in ...and limit potential multifunctional, self-healing, ultraphob / ultraphil • Other Examples: more detail as it was performed in this project risks? Drug targeting • To evaluate the benefit of the new nanomaterial Risks: • Remediation in relation to the conventional one a life cycle •Enhanced mechanical properties: assessment (LCA) has to be performed Seen through the recycling • Which functionality of the hazardous substance properties of nano- •Large surface/interface: toxicity could be provided by which NT. materials •Ethical questions: human enhancement? military use? NT in Chemical in Su Chemical NT

European Forum on N Forum European •“Nano-divide”? ... Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

European Parliament, DG Internal Policies of the Union, Directorate A: Economic and European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment) Nanologue: Dialogue about what? Who is really in charge of policy making in cutting edge technology? Consumer Steffi Friedrichs, Director, - No such thing as one NT protection Lisbon Nanotechnology Industries - NT is an emerging technology that will help to advance Nano- Toxicity Divide Policy maker Association emerging markets but will not have a market of is own - Existing regulations in appropriate areas (REACH) NGOs Researcher, cover what is needed Engineers Standar Pat Mooney, Executive - There should be a NT moratorium tunity ? anosciences

disatio r Director, ETC G roup, C anad a - Industrial revolution without having any rules and Military n Social regulations at place Use Societal scientists Cecilia Malmström, Minister - Need for transparency Business aspects of NT for EU Affairs, Swedish Ethics, Prime Minister’s Office values IPR Journalists Kjell Andersson, Managing - European Transparency Arena for political insight and SciFi authors Director, Karita Research accountability

Public Stories Anders Wijkman, MEP - Need to have some legislation on the issue of NT

Grey -NT oppo or threat Acceptance member of the STOA Panel Nano- Goo - It is unclear how such legislation would look like European Forum on N Forum European Robots - Working group looking at this

Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

4 European Parliament, DG Internal Policies of the Union, Directorate A: Economic and Scientific Policy, Policy Department, STOA (Science & Technology Options Assessment)

Thank you for your attention !

STOA website: http://www.europarl.europa.eu/stoa/default_en.htm

[email protected], [email protected]

Working and Living with Nanotechnologies, 2 April 2009, European Parliament Brussels

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29-7-2009

ETUC resolution on ETUC nanotechnologies and nanomaterials ETUC is the European social partner representing workers. The Treaty of Maastricht (1992) guarantees this formal status.

Together with the employers, it is involved in consultation in areas Final NanoCap Conference such as employment, social affairs, macroeconomics, industrial and Brussels, 2 April 2009 regional policy.

Joël Decaillon 82 member organisations 36 European countries Confederal Secretary ETUC 12 industry federations 60 million workers

ETUC Contribution Preamble z Members of the ETUC came together in a WG Nano and prepared The ETUC is convinced that nanotechnologies a European Trade Union position .

and manufactured nanomaterials might have z Resolution adopted by the ETUC’s Executive committee in June considerable development and application 2008. It’s the common position of all the trade unions in Europe. The ETUC represents 60 million workers. potential. 9 Technological improvements z The contribution of the ETUC, its member federations and confederations is to point out essential elements of the European 9 New jobs policy for a responsible and sustainable development of nanotechnologies.

z The ETUC Resolution is also a contribution to the EC Action Plan on Concerns about potential risks to human health & Nanotechnologies and Nanosciences 2005/2009, which calls for a environment. risk assessment on health, environment, consumers & workers.

Health & Safety at work must be a priority

ETUC Resolution Marketing

The regulatory challenge is to ensure that society can benefit from REACH’s “No data = No market” must apply: (Art. 5 REACH) novel applications of nanotechnology, whilst a high level of Nanometre forms of chemicals should not be allowed on the market protection of health, safety and the environment is maintained. unless, sufficient data are supplied by manufacturers to show there (EC: COM 2008.366) are no harmful effects for human health and the environment;

The ETUC Resolution addresses the following issues: Registration procedure in REACH: (Art. 6, 7 …REACH) Mus tbt be modifi difidied in or der to cover a ll nanoma ter ilials, inc ldiluding those ÎMarketing produced or imported in quantities below 1 tonne per year; ÎWorkers Protection ÎR&D Chemical Safety Report: (Art. 14, Annex I REACH) ÎTerminology ÎLegislative framework in the EU Chemical safety assessment must be done for all REACH-registered substances for which a nanometre scale use has been identified. ÎConsumers protection ÎPrecautionary Principle & application Communication & Implementation of risk management measures for human health & environment

1 29-7-2009

Workers Protection R&D z Increase budge for H&E aspects: z Risk assessment: Involve workers and/or their representatives Imbalance between budgets for the development of commercial in the assessment and reduction of nanomaterial-related risks; applications and those for research into the potential impacts on human health and the environment: z Risk reduction: Amend Chemical Agents Directive 98/24/EC, to require employers to implement risk reduction measures when the dangers of substances used are still unknown; To allocate at least 15% of public research budgets on nanotechnologies for health and environmental aspects; z Safety Data Sheets (Art. 31 REACH): Improve workers’ information about nanomaterials that may be present in z H&S Reporting: To require all research projects to include H&S products to which they are exposed: Safety data sheets must issues as a compulsory part of their reporting. state whether nanomaterials are present; z Exposure controls: Provide training and health surveillance for workers exposed to nanomaterials. Make health and safety at work issues a compulsorycompulsory part part of allall research research projects projects

Terminology Legislative Framework z A standardised terminology for nanomaterials is z ETUC's examination of the current legislative framework has urgently needed to prepare meaningful regulatory identified several loopholes. Some regulatory changes are needed. programmes. z Amend Chemical Agent Directive & REACH for a better coverage to all potentially manufactured nanomaterials; (below 1Ton/year, Chemical Safety Report) z ETUC ca lls on the EU Comm iss ion to a dop t a definition of nanomaterials which is not restricted to Precautionary approach: Meaning that the exposure should be objects below 100 nanometers in one or more avoided as much as possible. These substances must be dimensions. considers as very hazardous chemicals.

z Voluntary initiatives & codes of practices are useful if some To avoid nanomaterials already on the market be out conditions are met, but nanotechnologies need proper legislation. of the scope of future legislation To avoid risks, avoid exposure

Consumers & Products Precautionary Principle

Priority Principle in REACH z Label: Right to know what’s in a product. ETUC wants all consumer products containing manufactured nanoparticles Preventive actions must be taken where uncertainty which could be released under reasonable and foreseeable prevails & given the deficit of knowledge. conditions of use or disposal to be labelled. z National Register: ETUC calls on Member states authorities to set up a national register on the production, import and use of nanomaterials and nano-based products. This means that precautionary principle must be applied Easy to identify where responsibility lays for any harmful effect This is the essential prerequisite for the responsible development of nanotechnologies and for helping ensure society’s acceptance of nanomaterials.

2 29-7-2009

Factual application of the PP Achieve the benefits of Shifting the burden of the proof to the proponent of the substance nanotechnologies while preventing to demonstrate its safety. a nano-disaster

This ppgrevents damage while new information accumulates. “After the asbestos scandal , the ETUC finds it unacceptable that products should now be Examples of the application of the PP can be found in the ETUC Resolution in 2 areas, concerning: manufactured without their potential effects on human health and the environment being known • The process of Registration of a Substance in REACH unless a precautionary approach has been • The implementation of Risk assessment for all applied and made transparent to the workers”. nanomaterials

Thank You

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ANNEX II: Description Speakers and Panel Members

Conference “Working and Living with Nanotechnologies”

SHORT DESCRIPTION SPEAKERS AND PANEL MEMBERS

Antonis Angelidis Mr. Angelidis is chemical engineer who joined the Commission in 1990. He had been working for six years in the Directorate General of Energy and in particular in Euratom as a nuclear inspector. He then joined the Directorate General of Employment, Social Affairs and Equal Opportunities and since 1996 he is working in the Health and Safety at Work Unit. He is responsible for the development and the implementation of the Unit's prevention policy in the field of chemical substances. He is leader of the Unit's chemical group.

Frank Barry Workers Representative member of AMICUS/ UNITE President / Vice President for AMICUS Ireland and England 2000/2001 National Executive member for AMICUS /UNITE Ireland Chairperson of the Sub- committee on developing a policy strategy for the HSA on the safe use of nano- materials in research and manufacturing by workers. Member of the EU Nanocap project

Pieter van Broekhuizen Pieter van Broekhuizen studied biochemistry at the Technical University in Delft and at the University of Amsterdam. He is manager of the unit Nanotechnologies and Chemical Risks of IVAM research and consultancy institute related to the University of Amsterdam. He was director of the Chemiewinkel, the Consultancy and Research Centre on Chemistry, Work and Environment at the same University. They merged with IVAM UvA BV in 2002. The unit Nanotechnoloy and Chemical Risks covers the interface between nanotechnologies, occupational health and safety, the environment and chemistry. He is member of the Dutch Social Economic Council’s subcommittee on the setting of occupational exposure limits. He is involved in nanotechnologies and their possible impact on man and the environment. He coordinates the European project NanoCap and participates in different other nanotechnology projects.

Dorette Corbey Dorette Corbey is member of the European Parliament for the Socialists Party. Member of the Committee on the Environment, Public Health and Food Safety and the delegation for relations with the People's Republic of China. She is the substitute in the Committee on Fisheries and in the Committee on Industry, Research and Energy.

Jan Cremers Jan Cremers is member of the European Parliament Socialist Party. He is expert in the field of working conditions. In the end of the eighties he was chosen to become European trade union official, where he gave his support in the realisation of European social legislation concerning the free movement of workers and the occupational health and safety legislation. In 2000 he became director of the GBIO, the Dutch organisation for the education of works councils. He was senior researcher at the GITP advice and coaching institute and guest researcher at the Amsterdam Institute of Labour Studies (AIAS).

Joël Decaillon Joël Decaillon is a graduate in European law from the University of the Sorbonne (Paris). He is a trade union official of nearly 30 years’ standing, and was a member of the European Economic and Social Committee for 11 years. He is a member of the CGT’s Executive Committee and, since May 2003, he is the Confederal Secretary of the ETUC.

Laura Degallaix Laura DEGALLAIX is the Head of the Environment and Safety Department at BEUC, the European Consumers’ Organisation. She is responsible for preparing and agreeing BEUC’s positions and activities on all environment and safety issues. She works closely with the environment and safety officers in all 41 BEUC member organisations of 30 European countries. She represents BEUC at meetings and conferences in Brussels and around Europe. She is responsible for developing and implementing political strategy to force change to EU policy in the consumer interest. She is notably working on product safety, addressing both technical aspects of products and the content on chemical substances such as nanomaterials, and on environmental issues such as sustainable consumption and production and energy efficiency.

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Conference “Working and Living with Nanotechnologies”

In relation to nanotechnologies, Laura Degallaix has been particularly active on nanomaterials contained in cosmetic products, in the context of the recast of the cosmetics Directive. She is also working closely with BEUC member organisations on consumer perception of nanotechnologies and risk communication. Laura Degallaix graduated in biochemistry and environment and worked in the French National Museum of Natural History in Paris. She then worked at the French consumer organisation UFC-Que Choisir, member organisation of BEUC, in Paris as policy advisor on environment and sustainable development issues.

Miklós Györffi Educated in Romania and Hungary he got his doctor degree in physics in Debrecen and in technology assessment in Budapest. In 2005 he joined the European Parliament, DG Internal Policies Directorate A, Economic and Scientific Policy, Policy Department, administrator working for STOA (Science and Technology Options Assessment) Panel (previously also for ITRE Committee - on Industry, Research and Energy)

Malcolm Harbour Malcolm Harbour was elected to the European Parliament in June 1999, and re-elected in June 2004. He has been re-adopted as a Candidate for the 2009 Elections. He is one of 3 Conservative members representing the West Midlands Region of the UK. He is a Member of the Internal Market and Consumer Protection Committee, and has served as elected Co-ordinator for the European Centre Right Group (EPP-ED) since 2004. He is also a Member of the Industry, Research and Energy Committee. He is Conservative spokesman on Internal Market issues, and specialist spokesman on IT issues. He is Vice-Chairman of the Parliament's Science and Technology Options Assessment Panel (STOA) and a Member of the Inter-Parliamentary Delegation to Japan, a country he visits regularly. Malcolm Harbour takes a special interest in the EU single market, industry, science and technology policy. He is Chairman of the Forum for the Automobile and Society, the Ceramics Industry Forum and the Conservative Technology Forum. He is a Governor of the European Internet Foundation, a member of the Conservative Policy Review on Science and Innovation and the joint policy team with CDU and CSU MPs. In 2005, he served on the CARS 21 High Level Group, a Europe-wide initiative to boost the automotive industry. He was named as a top 50 European of 2006 for his key role in broking agreement on the Services Directive. In May 2006, he was named the UK’s most Small Business Friendly UK Parliamentarian by members of the Forum of Private Business. Before his election to the Parliament, Malcolm Harbour spent 32 years in the motor industry, as an engineer, a senior commercial executive, a consultant and a researcher. He began his motor industry career in the BMC Longbridge Plant as an Austin Engineering Apprentice in 1967.

John Hontelez John Hontelez has been the Secretary General of the European Environmental Bureau since December 1st, 1996 Other current positions: - Member High Level Group on the Reduction of the Administrative Burden (Chaired by Mr. Edmund Stoiber) – advisory body to the European Commission. - Member (on behalf of environmental organisations) of the Bureau of the Aarhus Convention (UNECE Convention on Access to Information - Member Board Institute for Sustainable Development, Warsaw, since 1996. - Member Coordination Board Ecoforum (a Pan-European network of Environmental Citizens Organisations), since 1994 and Chair of its Public Participation Campaigns Committee.

Lena Perenius Lena Perenius was appointed Executive Director for the Programme Product Stewardship in November 2007; she joined Cefic in 2002 as Director REACH Implementation. The core activities of the Programme Product Stewardship are focused on supporting the Chemical Industry with respect to proactive management of industry involvement at EU and International level in ¾ Chemical legislation ¾ Voluntary initiatives ¾ Management of emerging issues related to new or existing products ¾ Product Stewardship by improving interactions in the entire value chain on product safety. A Swedish national, Lena Perenius has a degree in chemistry (biochemistry/microbiology) from the Stockholm University. She has more than 25 years of work experience with industry, national authorities, the European Commission and trade associations. In Sweden she worked 8 years for the pharmaceutical industry and 11 years for Authorities, mainly for the Chemicals Inspectorate.

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Conference “Working and Living with Nanotechnologies”

She joined the Commission, DG Industry, in 1996 with responsibility for harmonisation of chemicals legislation, notably restrictions on the marketing and use of dangerous substances.

Henrik Laursen Henrik Laursen is administrator in DG Environment. He has been working with environment policy matters for the last 18 years and has covered a broad range of issues from climate change to phthalates in toys. Since November 2007 he has been working in DG Environment's Chemicals unit where he is the coordinator of DG Environment's policy on nanomaterials. His main tasks include being in charge of the Commission's input to the OECD Working Party on Manufactured Nanomaterials as well as working on the legal situation within the EU in the so-called "Competent Authorities Subgroup on Nanomaterials" (CASG Nano) which was established in 2008 under REACH.

Tony Musu Tony Musu is a Chemical Engineer by education and he holds a PhD in Science from the Pasteur Institute in Paris. Before his current position in the Research Institute of the European Trade Union Confederation (ETUI/ETUC), he spent five years in the industry dealing with the safety assessment of chemicals. Since 2003, he has been participating on behalf of ETUC in various REACH-related Commission working groups. In 2007, he was appointed in the Management Board of the European Chemicals Agency (ECHA) where he represents European workers. He is also a member of the Ad Hoc WG on Chemicals within the Luxembourg Advisory Committee on Health & Safety at work.

Ben Nemery Professor Ben Nemery is head of the Research Unit of Lung Toxicology of the Department of Public Health, Faculty of Medicine, of the Katholieke Universiteit Leuven. This research unit is a joint-venture between the division of Occupational, Environmental and Insurance Medicine and the division of Pneumology. During the last decade, the laboratory has grown to a medium-sized group of about ten researchers at pre-doctoral and post- doctoral level. It has built up a good international reputation in the field of occupational and environmental pulmonary toxicology, including “nanotoxicology”, and it is involved in various EU initiatives around the health and safety aspects of nanotechnology. Ben Nemery is actively involved in several national and international bodies, including the European Respiratory Society, where he holds positions in the scientific leadership, and the American Thoracic Society.

Alfred Nordmann Alfred Nordmann is Professor of Philosophy and History of Science at Darmstadt Technical University, Germany. Since 2000, his research focused on nanotechnology as a symptom of larger changes of the culture of science and the relation of science and society. He served as rapporteur of the European Commission's expert group Converging Technologies – Shaping the Future of European Societies (2004). Nordmann heads the nanoOffice which recently proposed an institutional model for the "regulation" of nanotechnology (www.nanoOffice.eu). Recent publications include • "Philosophy of Nanotechnoscience" in G. Schmid (ed.) Nanotechnology: Volume 1: Principles and Fundamentals, Weinheim: Wiley, 2008, pp. 217-244.

Dragomira Raeva Dragomira Raeva has re-joined the EEB as the EU policy officer for Clean Air, Nanotechnology and Noise Reduction in September 2007. Prior to joining the EEB, Dragomira has been working with the Lund Municipality in Sweden, where she helped the local mobility management team in developing and implementing environmentally friendly transportation services. She has also been a long term trainee at the EEB assisting the works on air, noise and urban environment issues. Dragomira has been an active member of the environmental NGO Za Zemiata in Bulgaria, where she facilitated the organization of capacity building workshops, trainings and campaigns on various environmental topics. Dragomira’s academic training is in Environmental Science, Policy and Management. She completed her master’s degree in a joint programme between the Central European University in Budapest and the Institute for Industrial Environmental Economics in Lund. Her thesis is in the field of sustainable urban transport and development and running of mobility management practices in European cities.

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Conference “Working and Living with Nanotechnologies”

Lucas Reijnders Prof dr. L. Reijnders (1946) studied biochemistry at the University of Amsterdam and got his PhD in molecular biology from that university in 1973. After that he worked in teaching positions at the Agricultural University of Wageningen and the State University of Groningen. Since 1988 he is professor of environmental science at the University of Amsterdam, and since 1999 he holds the same chair at the Open University of the Netherlands. His main publications in the field of nanotechnology are: • Cleaner nanotechnology and hazard reduction of manufactured nanoparticles. Journal of Cleaner production 14 (2006) 124-133 • Biological effects of nanoparticles used as glidants in powders. Powder Technology 175 (2007) 142-145 • Hazard reduction for the application of titania nanoparticles in environmental technology. Journal of Hazardous Materials 132 (2008) 440-445 • Hazard reduction in nanotechnology. Journal of Industrial Ecology 12 (3) (2008) 297-306 • The release of TiO2 and SiO2 nanoparticles from nanocomposites. Polymer Degradation and Stability 2009; in press Carl Schlyter Carl Schlyter is chemical engineer specialised in biotechnology and the environment (at the Royal Institute of Technology, Stockholm). He is member of the European Parliament for the Group of the Greens/European Free Alliance (Verts/ALE). He is member of the Committee on the Environment, Public Health and Food Safety (Member) and the Delegation to the ACP-EU Joint Parliamentary Assembly (Member). He is substitute in the following committees: the Committee on Budgetary Control, the Committee on Fisheries and the Committee on International Trade . Het is substitute for the delegation for relations with the countries of Southeast Asia and the Association of Southeast Asian Nations (ASEAN).

René von Schomberg Dr. Dr.phil. Rene von Schomberg is an agricultural scientist and philosopher. He holds Ph.D's from the University of Twente (NL) (Science and Technology Studies) and J.W.Goethe University of Frankfurt (D) (Philosophy). He has been based at various universities and is now with DG Research of the European Commission. He is author/co-editor of 12 books, most recenty: • Implementing the Precautionary Principle, Perspectives and Prospects, co-edited with E. Fisher and J. Jones, E.Elgar Publishers, 2006 and the Working Paper of the services of the EC on the ethics of new technologies (see conference bag).

Willem-Henk Streekstra Willem-Henk Streekstra is for 3 years now senior adviser environmental affairs for the Confederation of Netherlands Industry en Employers (VNO-NCW). Within VNO-NCW he coordinates the work on riskpolicy of nanotechnologies. VNO-NCW pursues an active approach on risk policies of nanotechnologies. This means she tries to turn the precautionary principle into concrete and workable measures to make risks of nanotechnologies manageable. In former jobs he was a lobbyist for the Dutch agriculture.

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